Z-0855-05

Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair...

Name: Z-0855-05 Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair...
Creator: Arizant Inc
Published: 2005-03-11
License: https://open.fda.gov/license/

Arizant Healthcare, Inc. / initiated 2005-03-11 / Terminated

FDA source

Arizant Inc began a recall of Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair Hugger temperature managemen unit. Not Sterile. Do... on 2005-03-11. The reason FDA records is "Air channel seals on a limited number of Bair Hugger Model 555 Pediatric underbody blankets could separate when inflated with air from Bair Hugger warming unit. This separation would create a bulging area in the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0855-05
Status: Terminated
Initiated: 2005-03-11
Posted: 2005-06-01
Terminated: 2007-01-10
Recalling firm: Arizant Healthcare, Inc.
Product: Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair Hugger temperature managemen unit. Not Sterile. Do not use if primary packaging has been previously opened or is damaged. Arizant Healthcare Inc., 10393 West 70th Street, Eden Prairie, MN 55344 USA.
Product code: DWJ System, Thermal Regulating
Reason for recall: Air channel seals on a limited number of Bair Hugger Model 555 Pediatric underbody blankets could separate when inflated with air from Bair Hugger warming unit. This separation would create a bulging area in the blanket's air channels, which could have a potential to shift the patient's position on the blanket.
FDA root cause: Other
Action: Recall notification was mailed to customers beginning 03/11/05. Customers were informed of the issue and asked to check their inventory for the affected lots. Affected lots found are to be quarantined and customers are to contact Arizant for instruction on returning affected product and receiving replacement product. Distributors are instructed to examine their inventory for affected lots, discontinue distribution and quarantine the lots. Distributors are asked to contact Arizant for returning affected product. If affected product was distributed, Distributors are to contact Arizant with names, addresses and telephone numbers of their accounts so Arizant can immediately inform those accounts of the recall.
Quantity in commerce: 88,320 blankets
Distribution: nationwide
Product codes and lots: lot numbers ranging from 9631 up to and including 9657

Product code DWJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)